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EC number: 263-058-8
CAS number: 61789-40-0
The prenatal developmental toxicity
study following OECD guideline 414 was performed on female CD rats. Test
material was soluble in water (aqua ad iniectabilia). Dose concentration
were prepared at 0, 330, 990 or 3300 mg/kg-day (corresponding to 0, 95,
286, and 950 mg/kg-day active substance, respectively) and administered
in a dose volume of 10 ml/kg bw from day 5 to 19 of pregnancy once daily
via gavage. 25 female rats /dose group were treated and 20 pregnant
animals were evaluated. 20 rats (0, 330, 990 mg/kg bw group) and 21 rats
(3300 mg/kg bw group) were evaluated for maternal toxicity. 1 male and 1
female were placed in one cage during the dark period. Mating was
repeated until vaginal smear showed presence of sperm. All animals were
observed for clinical signs, Body weight and food consumption daily.
Also number of fetuses alive, Weight of fetuses, sex distribution of
fetuses, skeletal anomalies (50 %) and soft tissue anomalies (50 %) were
noted. One dam at 3300 mg/kg day died on gestation day 15 and in same
dose group 13/21 abdominal position, 2/21: pilo-erection, reduced
motility was noted. At≥990 mg/kg bw dose group, reduction of the
net weight change (carcass weight minus day 6 body weight) from day 6
onwards (23% and 67%) and reduced food consumption (up to 12 % gestation
days 8, 10, 19), 4/20: ulcers, thickened mucosa were observed. At 3300
mg/kg bw dose group, reduced body weight (up to 17 % below control) and
decreased body weight change, reduced food consumption up to 65% each
day, reduced gravid uterus weight by 22% (caused by lowered fetal
weights) and 20/21: thickened mucosa, greyish discolored in 2/21; ulcers
(also in the prematurely deceased dam) were observed. The number of
early, late and total resorptions was increased in the 3300 mg/kg bw
group. Moreover the ratio of viable fetuses to implantation sites was
decreased compared to the controls. This was due to a total
post-implantation loss of two dams in this dose group. A statistically
significant reduction in fetal weights and number of viable fetuses as
compared to the control was observed. At 3300 mg/kg bw dose group. No
external, skeletal or soft tissue malformations and no external
variations were seen in controls or in dosed groups. The fetal incidence
of the skeletal variations was 5 in the controls and 8 (330 mg/kg bw),
13 (990 mg/kg bw) and 6 (3300 mg/kg bw) in the test group respectively.
The finding in the 990 mg/kg bw group was judged as incidental as no
dose-relationship was noted. The skeletal retardations (fetal incidence)
were 129 in the controls and 137 (330 mg/kg bw), 130 (990 mg/kg bw) and
125 (3300 mg/kg bw) in the dosed groups. No dose-related soft tissue
variations were observed, as seen in the following fetal incidences: 8
(control), 12 (330 mg/kg bw), 10 (990 mg/kg bw) and 9 (3300 mg/kg bw).
Hence, the NOAEL for maternal toxicity was 95 mg/kg bw/day and the NOAEL
for reproductive and developmental toxicity was >950 mg/kg bw/day as the
post-implantation loss and decreased mean fetal body weight were
considered to be secondary to maternal toxicity when female CD rats were
treated with test chemical orally from day 5 - 19 of pregnancy.
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